DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of claims: claims 1-19 are pending below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/18/2025 and 2/3/2025 was filed and considered. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 3-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,733,150. Although the claims at issue are not identical, they are not patentably distinct from each other because the invention defined by the claims of the instant application would have been obvious to one of ordinary skill in the art in view of the claims of U.S. Patent No. 11,733,150. Independent claims 1, 18 and 19 of the instant invention is anticipated by independent claims of 1 and 20 of U.S. Patent No. 11,733,150. Dependent claims 3-17 follow likewise mapping to dependent claims 2-19 and 21-28 in U.S. Patent No. 11,733,150.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,733,150in view of Dong et al (US 2005/0089208).
Claim 3:
U.S. Patent No. 11,733,150 anticipated the following subject matter above regarding blood, but not the following which is taught by Dong et al:
The apparatus according to claim 1, wherein the microscope system is configured to acquire the first and second images of the sample by acquiring first and second at least partially overlapping images of a portion of the sample (paragraph 0011, claim 14 and 29 teaches imaging with overlapping between first and second images of the sample of interest).
U.S. Patent No. 11,733,150 and Dong et al are in the same field of image analysis by means of first and second image of target region using a microscope such that the combine outcome is predictable.
Therefore it would have been obvious to one having ordinary skill before the effective filing date to modify U.S. Patent No. 11,733,150 by Dong et al such the images can be used to analyze image characteristics may include, for example, texture energy, entropy, contrast, and/or sharpness as disclosed in 0011.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,196,664. Although the claims at issue are not identical, they are not patentably distinct from each other because the invention defined by the claims of the instant application would have been obvious to one of ordinary skill in the art in view of the claims of U.S. Patent No. 12,196,664. Independent claims 1, 18 and 19 of the instant invention is anticipated by independent claim 1 of U.S. Patent No. 12,196,664. Dependent claims 2-17 follow likewise mapping to dependent claims 2-20 and 21-28 in U.S. Patent No. 12,196,664.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 3-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ortyn et al (US 2010/0232675) in view of Lin et al (US 2004/0241677).
Claim 1, similar claims 18 and 19:
Ortyn et al teach the following subject matter:
An apparatus for use with a microscope system, an output device, and a blood sample that was drawn from a subject (0011-0013 teaches method and apparatus for analyzing blood/erythrocyte), the apparatus comprising:
a computer processor (0153-0156 teaches the require image processing including computing devices with processor such as laptop, networked, mainframe, hand-held, and other that include a processor and a memory in the execution of plurality of functions) configured to:
drive the microscope system to acquire first and second images of the blood sample at respective times (0006 teaches the use of microscope for diagnostic evaluation; figure 3 part 402 teaches image data from first cell/blood and part 406 teaches image data from second cell/blood using the microscope disclosed above; 0023-0025 teaches where the cells can be acquired at different times to aid in quantifying cellular changes over time).
Ortyn et al teach all the subject matter above, but not the following which is taught by Lin et al:
determine whether, between acquisitions of the first and second images (figure 3 teaches first and second time between step 330-379 and loop back to 330 again, as well as step 398 repeating for another/second image to be taking to determine parasitemia level, strain identification or stage identification between image acquisitions; 0043-0064 detail figure 3), there was motion of an entity, by comparing the first and second images to one another (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary),
at least partially in response thereto, identify the entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell (erythrocyte) due to pixel analysis in regarding to falling in/outside (intra/extra) boundary; 0058 teaches determination of anomalous bodies inside as well as outside the red-blood-cell), and
generate an output on the output device, at least partially in response thereto thereto (0056 teaches output regarding blood cell gone and parasite candidates remain would help conclude the characteristic of this sample; 0058 output anomalous bodies inside and outside red-blood cell help conclude the food print of the sample; 0064 teaches outputting analysis of shape characteristic of the parasite such as spherical, elongated, ring-shaped, banana-shaped to show different stages and different strains with generating/output data to indicates the species, distribution is view as characteristic as well).
Ortyn et al and Lin et al are both in the field of image analysis especially in the interaction between red blood cell and anomalous entity in time digital imaged samples such that the combine outcome is predictable.
It would have been obvious to one skill in the art at the time of the invention to modify Ortyn et al by Lin et al regarding determination of entity in/outside of the red-blood cell to correctly classify the sample to prevent miss detection and lethal consequence as disclosed by Lin et al in paragraph 0011.
Claim 3:
Ortyn et al further teach:
The apparatus according to claim 1, wherein the computer processor is configured to drive the microscope system to acquire the first and second images of the blood sample at respective times by driving the microscope system to acquire the first image of the blood sample during a first scan of the blood sample in which a plurality of images of the blood sample are acquired from respective fields of view (figure 3 part 402 teaches image data of first population which can be view first scan; abstract disclose plurality of images such as multimodal and multispectral image of cells from population of cells are collected which is view as apply to first scan), and by driving the microscope system to acquire the second image of the blood sample during a second scan of the blood sample in which a plurality of images of the blood sample are acquired from respective fields of view (figure 3 part 406 teaches image data of second population can be view as second scan; abstract disclose plurality of images such as multimodal and multispectral image of cells from population of cells are collected which is view as applying to second scan as well).
Claim 4:
Lin et al teach:
The apparatus according to claim 1, wherein the computer processor is configured to perform a blood count of the subject (0053 teaches counting of red cell and white blood cells as well, where white blood cell are the entity outside of red blood cell; 0059 teaches counting of anomalous bodies/entity that are inside the cell, parasite footprints), at least partially based upon identifying the entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary; 0058 teaches determination of anomalous bodies inside as well as outside the red-blood-cell), and the computer processor is configured to generate the output by generating an indication of the blood count (0053 teaches counting of red cell and white blood cells as well, counting is the output generated regarding the blood count).
Claim 5:
Lin et al teach:
The apparatus according to claim 1, wherein the computer processor is configured to diagnose the subject as suffering from an infection (0014 teaches diagnosed such as malaria which is an intra-erythrocytic infection with human/subject examination, where 0015 teaches such diagnosed can be automated/computer process), at least partially based upon identifying the entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary; 0058 teaches determination of anomalous bodies inside as well as outside the red-blood-cell), and the computer processor is configured to generate the output by generating an indication of the diagnosis (0014-0015 teaches diseases can also be diagnosed by human examination with automated examination to classify/output the candidates as such parasites).
Claim 6:
Lin et al teach:
The apparatus according to claim 1, wherein the computer processor is configured to diagnose the subject as suffering from a medical condition (0014 teaches diagnosed such as malaria which is an intra-erythrocytic infection/medical infection for human/subject examination, where 0015 teaches such diagnosed can be automated/computer process), at least partially based upon identifying the entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary; 0058 teaches determination of anomalous bodies inside as well as outside the red-blood-cell), and the computer processor is configured to generate the output by generating an indication of the diagnosis (0014-0015 teaches diseases can also be diagnosed by human examination with automated examination to classify/output the candidates as such parasites).
Claim 7:
Ortyn et al further teach:
The apparatus according to claim 1, wherein the computer processor is configured to drive the microscope system to acquire the first and second images by acquiring the first and second images of the blood sample, while the blood sample is in a stained state (above teaches acquiring first and second population images data; 0099-0103 teaches application of different color fluorescent dye which is view as stained).
Claim 8:
Ortyn et al further teach:
The apparatus according to claim 1, wherein the computer processor is configured to generate agitation of the blood sample between acquisitions of the first and second images (0078 teaches consideration of imaging quality relative between the detector and the objects being imaged: photo charge shift rate with image of the cell; 0086 teaches relative movement (amount of agitation) exist between object being imaged an the imaging system; 0008 teaches where red blood cells as samples that are being imaged).
Claim 9:
Ortyn et al teach:
The apparatus according to claim 1, wherein the computer processor is configured to: drive the microscope system to acquire the first image of the blood sample by driving the microscope system to acquire a first set of images of the blood sample that includes a plurality of images (0006-0010 teaches the use of microscope for diagnostic evaluation; figure 3 part 402 teaches image data from first population of cell; 0013-0016 teaches plurality of images/collection of multispectral images); drive the microscope system to acquire the second image of the blood sample by driving the microscope system to acquire a second set of images of the blood sample that includes one or more images; and compare the first and second images to one another by comparing one or more of the images belonging to the first set of images to respective images belonging to the second set of images (figure 3 part 408 teaches analyzing of both image data from both first and second cell populations; 0014 teaches analyze subpopulation/portion of the population imaged).
Claim 10:
Ortyn et al further teach:
The apparatus according to claim 9, wherein the computer processor is configured to compare only some of the first set of images to respective images belonging to the second set of images, and to determine a characteristic of all of the blood sample based on the comparison (above teaches first and second images; 0075 teaches plurality of first and second images due to multispectral images by photometric and morphological image features with multi-mode to discriminate cell characteristics in cell population; 0074 teaches where selected pairs/subsets (selected from plurality of first to second from the multispectral images above) of imaging are compared for different characteristic such as shape, position, ratio, density, relative placement).
Claim 11:
Ortyn et al further teach:
The apparatus according to claim 9, wherein the microscope system is configured to drive the microscope system to acquire the second set of images by driving the microscope system to image a portion of the blood sample that is smaller than a portion of the blood sample that was imaged by acquiring the first set of images (above teaches first and second images of blood samples; 0075 teaches plurality of first and second images due to multispectral images by photometric and morphological image features with multi-mode to discriminate cell characteristics in cell population; 0074 teaches where selected pairs/subsets (selected from plurality of first to second from the multispectral images above) of imaging are compared; 0128-0132, especially 0128 teaches total intensity (first image) and the smaller portion image set such as small total, where small total is view as the smaller portion of data extracted).
Claim 12:
Ortyn et al teach:
The apparatus according to claim 11, wherein the computer processor is configured to: analyze the first set of images; and based upon the analysis, select the portion of the blood sample to image in the second set of images (figure 3 part 408 teaches analyzing of both image data from both first and second cell populations; 0014 teaches analyze subpopulation/portion of the population imaged).
Claim 13:
Ortyn et al further teach:
The apparatus according to claim 1, wherein the computer processor is configured to: determine whether the entity is disposed inside a second entity (0115-0119 teaches quantitative data treating erythrocyte lysing agent to erythrocyte with each cell further imaged to enable “list mode” inspection of any population of cells, where platelets are noted and considered as taught in 0008; list mode is view as listing all in the vicinity; figure 4 teaches cellular area/vicinity considered). Lin et al teach: by determining whether, between acquisitions of the first and second images, there was relative motion of the entity relative to the second entity, and identify the entity based on whether the entity is disposed inside the second entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary).
Claim 14:
Lin et al teach:
The apparatus according to claim 13, wherein the computer processor is configured to determine whether the entity is disposed inside the second entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary; 0058 teaches determination of anomalous bodies inside as well as outside the red-blood-cell), at least partially based upon an amount of motion between the entity and the second entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary), and a time interval between acquisitions of the first and second images (figure 3 teaches first and second time between step 330-379 and loop back to 330 again, as well as step 398 repeating for another/second image to be taking to determine parasitemia level, strain identification or stage identification between image acquisitions; 0043-0064 detail figure 3).
Claim 15:
Lin et al teach:
The apparatus according to claim 13, wherein the computer processor is configured to determine whether the entity is disposed inside the second entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary; 0058 teaches determination of anomalous bodies inside as well as outside the red-blood-cell), at least partially based upon an amount of motion between the entity and the second entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary).
Ortyn et al teach: and an amount of agitation applied to the blood sample between acquisitions of the first and second images (0078 teaches consideration of imaging quality relative between the detector and the objects being imaged: photo charge shift rate with image of the cell; 0086 teaches relative movement (amount of agitation) exist between object being imaged the imaging system; 0008 teaches where red blood cells as samples that are being imaged).
Claim 16:
Lin et al teach:
The apparatus according to claim 13, wherein the computer processor is configured to determine whether the entity is disposed inside the second entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary; 0058 teaches determination of anomalous bodies inside as well as outside the red-blood-cell), at least partially based upon an amount of motion between the entity and the second entity (0056 teaches vector/movement consideration between parasites/entity and normal red blood cell/erythrocyte due to pixel analysis in regarding to falling in/outside boundary), a time interval between acquisitions of the first and second images (figure 3 teaches first and second time between step 330-379 and loop back to 330 again, as well as step 398 repeating for another/second image to be taking to determine parasitemia level, strain identification or stage identification between image acquisitions; 0043-0064 detail figure 3).
Ortyn et al techg: an amount of agitation applied to the blood sample between acquisitions of the first and second images (0078 teaches consideration of imaging quality relative between the detector and the objects being imaged: photo charge shift rate with image of the cell; 0086 teaches relative movement (amount of agitation) exist between object being imaged the imaging system; 0008 teaches where red blood cells as samples that are being imaged).
Claim 17:
Ortyn et al further teach:
The apparatus according to claim 13, wherein the computer processor is configured to:
analyze the first image; based upon the analysis, identify one or more entities within the first image that are disposed in a vicinity of second entities; and at least partially in response thereto, select to perform the comparing of the first image and the second image to one another (0115-0119 teaches quantitative data treating erythrocyte lysing agent to erythrocyte with each cell further imaged to enable “list mode” inspection of any population of cells, where platelets are noted and considered as taught in 0008; list mode is view as listing all in the vicinity; figure 4 teaches cellular area/vicinity considered); and in response thereto, select to perform the comparing of the first image and the second image to one another (Figure 3 teaches comparing of first and second images data).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ortyn et al (US 2010/0232675) in view of Lin et al (US 2004/0241677) as applied to claim 1 above, and further in view of Dong et al (US 2005/0089208).
Claim 2:
Ortyn et al and Lin et al teaches the subject matter above regarding blood, but not the following which is taught by Dong et al:
The apparatus according to claim 1, wherein the computer processor is configured to drive the microscope system to acquire the first and second images of the blood sample by driving the microscope system to acquire first and second at least partially overlapping images of a portion of the blood sample (paragraph 0011, claim 14 and 29 teaches imaging with overlapping between first and second images of the sample of interest).
Ortyn et al and Lin et al and Dong et al are in the same field of image analysis by means of first and second image of target region using a microscope such that the combine outcome is predictable.
Therefore it would have been obvious to one having ordinary skill before the effective filing date to modify Ortyn et al and Lin et al by Dong et al such the images can be used to analyze image characteristics may include, for example, texture energy, entropy, contrast, and/or sharpness as disclosed in 0011.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bachelet et al (US 9,522,396) teaches Apparatus And Method For Automatic Detection Of Pathogens - FIG. 8, after the sample was dyed fluorescently the algorithm successfully tracked motion of florescent particles (indicated by arrows), and correctly identified this motion as typical in speed and direction to trypanosome parasites. An identification of trypanosome parasites was displayed onscreen. (157) 1. Prepare thin blood smears upon a cartridge, and capture images. Divide the images into fields of images. Analyze each field independently by recording a series of images from that field, effectively creating a clip of images. 2. For each frame, verify its validity using the Image Verification Module. If more than a specified number of consecutive images are poor (e.g. 4 images), report an error on this field. 3. Normalize the image to compensate for lighting variance, since typically the image is more strongly illuminated at its center. 4. For each frame in the clip, construct the background image using the Motion Field Construction Module. In thin blood samples it is possible to wait for the red blood cells to dry in order to use the simpler version of the algorithm (column 22 lines 45-67).
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/TSUNG YIN TSAI/Primary Examiner, Art Unit 2656
